Quality Engineer

Skip to main content Quality Engineer Detect Guilford, CT Apply Quality Engineer Detect Guilford, CT 3 weeks ago 123 applicants See who Detect has hired for this role Apply Save Report this job Direct message the job poster from Detect Adam Holtzberg Adam Holtzberg Recruiting and People Associate at Detect Company DescriptionDetect’s mission is to make accurate diagnostics accessible. We build breakthrough technology at the intersection of software, hardware, chemistry, and biology to make diagnostics available at the point of need. Our ultimate goal is to lower healthcare costs, improve patient outcomes, and improve doctor experience by enabling earlier diagnosis and access to treatment.Job DescriptionThe Quality Engineer is responsible for ensuring the effectiveness and compliance with ISO 13485, FDA Quality Management System Regulation (QMSR), and applicable regulatory requirements throughout the product lifecycle of molecular diagnostic and IVD products. This position provides oversight of quality system processes, product release activities, design control support, and validation programs.As part of our team, your core responsibilities will be to:Lead and maintain CAPA, NCR, Deviation, OOS, and OOT programsConduct investigations, root cause analyses, and effectiveness reviewsReview and approve Device History Records (DHRs) and release productsSupport FDA inspections, ISO 13485 audits, and management reviewsMaintain Design History Files (DHF), Medical Device Files (MDF), and design control recordsSupport risk management, design reviews, design transfer, and change controlReview validation protocols and reports (IQ/OQ/PQ, process, equipment, facilities, CSV)Drive continuous improvement and compliance initiativesQualificationsBaseline skills, experiences, and attributes:Bachelor’s degree in chemistry, Biology, Engineering, or related scientific discipline3+ years of experience in a Quality Engineering or Quality role within the medical device or IVD industry under an FDA/ISO regulated environmentExperience in molecular biology products or molecular diagnostic productsStrong knowledge of QMSR (21 CFR Part 820), ISO 13485, and GMP requirementsFamiliarity with validation principles and environmental monitoringExperience with electronic QMS preferredStrong attention to detail and documentation review skillsEffective problem-solving and cross-functional collaboration abilitiesYou Deeply Identify with Core Detect Values:Put people first. Our colleagues and our customers come first. We respect each other and celebrate our diversity. We take joy in each other’s success, and succeed or fail as a teamEye of the owner. We have an ownership mindset and take responsibility for all of our decisions. No problem is someone else's problem. We are frugal and use company resources as if they were our ownNo genius without grit. As innovators, we fail often but fast. We are tenacious. We push through adversity and keep getting up. We are problem solvers and always find a wayErr on the side of doing. We are scrappy and biased toward action — everyone is an individual contributor. We allow intuition to guide us when we have imperfect informationMove fast by working smart. We are inventors. We focus, plan, pursue, and adjust to make big things happen in a fraction of the time others can....